Drug Safety System & Data Analyst in Global Pharmacovigilance

Are you ready to set your footprints towards a digitally transformed future in Global Pharmacovigilance?

As our new Drug Safety System & Data Analyst you will ensure easy access to safety data and strengthen PV information and data management.

You will assess and analyse business requirements in collaboration with Line of Business and IT to recommend new or enhanced solutions supporting Global Pharmacovigilance strategy to improve our end-to-end processes. You will also provide drug safety application and operational support to users in our global pharmacovigilance organization, which has the responsibility for safety registry and surveillance of all LEO Pharma clinical and post marketed products.

You will be part of the PV System Support group within the PV System Compliance Department. The PV System Support group is supporting solutions used in Global Pharmacovigilance besides handling of all issues related to the drug safety application. Users of the system are located in Denmark, US, and India.

Global Pharmacovigilance is a great and desirable place to work where we respect our colleagues and are inspired to do our best every day

The Drug Safety System & Data Analyst job tasks:

  • develop standard data reports and perform ad hoc data extractions from the drug safety system
  • trouble shooting and supporting of users with drug safety system related issues
  • data quality checks
  • monitoring drug safety system performance and initiating corrective actions when needed
  • change management and deviations handling
  • develop and maintain drug safety system procedures and processes
  • maintenance of system master data
  • participate in drug safety system upgrades and IT projects as needed
  • participate in computer system testing and validation activities
  • provide drug safety system related trainings

The right candidate has the following knowledge, skills and experience:

  • Bachelor or Master degree in Computer Science, Computer Information Systems, Information Technology or Natural Sciences
  • 5+ years of experience within the pharmaceutical industry preferably in Drug Safety 
  • knowledge of Drug Safety Applications (e.g. ARISg, Argus)
  • experience with BI reporting tools (BO or Cognos preferred)
  • experience with system interfaces
  • knowledgeable of EU/FDA regulatory requirements and industry best practices for computerized systems validation
  • a fundamental understanding of EMA/ICH/FDA regulations for drugs and combination products particularly in the Pharmacovigilance area
  • ability to transform business requirements into operational solutions in alignment with business process needs
  • good ability to extract, analyze, interpret and present data
  • high level of accuracy and quality standards wit excellent documentation skills
  • ability to manage/coordinate projects or project-oriented tasks
  • dynamic, responsible, well-organized and with a positive and proactive mindset
  • strong written and oral communication skills
  • enjoy working in teams, a good laugh and close collaboration with colleagues

Your chance to play a key role

Would you like to join a dynamic, rapidly growing pharmaceutical company where people and their development are recognized as central to success? This is your chance to play a key role in the future digitally transformation of Global Pharmacovigilance and get a job with considerable individual responsibility, challenge, and the opportunity to develop your professional and personal competencies.

We look forward to welcoming you to our team!

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About LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions.
Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions.
LEO Pharma is headquartered in Denmark and employs around 4,800 people worldwide.
For more information, visit www.leo-pharma.com.
Application deadline: 08 Aug 2017

Location: Ballerup, Greater Copenhagen

Job type: Permanent

Working hours: Full-time

Working days: Day

Contacts: Irene Rasmussen
Mobile: +45 4137 1109